Director of Clinical Quality Assurance

Role Summary

Director of Clinical Quality Assurance responsible for embedding quality throughout the lifecycle of ongoing clinical programs, providing clinical quality support across study teams, and guiding the development of Alumis' Quality organization strategy and vision. Requires expertise in Good Clinical Practices and applicable US/EU regulations, and leadership to promote ethics, integrity, and proactive quality management.

Responsibilities

• Establish, maintain and enhance GCP QA programs, policies, and procedures.
• Ensure ongoing clinical programs are in compliance with applicable health authority regulations and guidelines.
• Act as the primary GCP QA subject matter expert and point of contact for all GCP/CSV related matters and issues for the assigned program, project or study.
• Establish the study specific audit plan ensuring successful execution and audit findings close out including CAPA management and oversight.
• Establish and manage the Quality Risk Management program.
• Represent Quality on project teams, Health Authority Inspections, service providers and CROs operational meetings, and QA to QA meetings.
• Support Quality Review meetings content and material. Prepare and manage Quality KPI and metrics.
• Provide quality oversight and review of key Clinical and IND/NDA enabling documents.
• Perform reviews of clinical trial documentation for data integrity and compliance with Good Clinical Practice guidance and regulations. Conduct root cause analysis for recurring issues.
• Partner in implementation of inspection readiness plans and activities. Act as the primary liaison with Development and Compliance team in execution of inspection and audit readiness plans including for internal/external and business partners audits.
• Support clinical service provider selection and qualification activities and develop periodic compliance/metric reports.

Education

• Bachelors or advanced degree in Biology, Chemistry, or related field.
• Minimum 10 years of Clinical Quality Assurance experience.
• Strong understanding of small molecule products with direct experience in solid oral dosage forms.

Knowledge / Skills / Abilities

• Extensive knowledge of FDA regulations and practices, ICH guidance, and strong knowledge of global health authority regulations and practices.
• Hands-on experience in drug life cycle management.
• A successful track record of working with service providers and CROs.
• Ability to make timely and sound quality decisions when faced with complex clinical, compliance, technical and regulatory considerations. Highly skilled in the ability to work with ambiguity and complexity.
• Knowledge of Quality Management Systems; experience in implementing and managing quality systems in the pharmaceutical industry.
• Excellent verbal and written communication skills.
• Collaborative, analytical and interpretative skills.
• Ability to work with minimal supervision, to set priorities to meet timelines, to motivate and influence others. Prior management experience is required.
• Previous experience in successfully leading assigned activities within cross-functional teams.
• Some travel required.